FDA faults company behind recalled eye drops for multiple violations, bans imports

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The FDA announced that it has moved to restrict imports of products manufactured by an Indian healthcare firm, after it urged the company to recall eye drops linked to an outbreak of 'extensively drug-resistant' bacteria across the country.

by the company, including a"lack of appropriate microbial testing" and a"lack of proper controls concerning tamper-evident packaging."

But testing of opened bottles of EzriCare eye drops from patients in two different states turned up bacteria matching the outbreak strain. The bacteria in the outbreak has taken hold in a range of different parts of the body for patients in the outbreak, ranging from respiratory infections to the urinary tract.

Symptoms can include pain or discomfort in the eye, as well as yellow, green or clear discharge coming out of the eye. Redness in the eye, increased sensitivity to light, and blurry vision can also be signs of an eye infection.

 

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The eye drops products marketed by Global Pharma Healthcare Private Limited under the brand names EzriCare or Delsam Pharma, are now being recalled. The FDA cited multiple violations of manufacturing regulations by the company, including a 'lack of appropriate microbial testing.”

Gonna go out on a limb here and say that fda has a whole lot more to worry about than eye drops.

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